Vaccination plays a major role in the control of seasonal influenza virus infection. In addition to the morbidity and mortality associated with annual influenza virus epidemics, there is an ever-present threat of the emergence of a global pandemic. It is estimated that a vaccine to a new pandemic strain produced using the current system of egg-based vaccine production would not be available for at least six months after the pandemic arises. Over the last three decades, speed, efficiency, and capacity of recombinant protein production have been greatly improved, providing new opportunities for generation of vaccines based on recombinant, purified antigens. In contrast to traditional vaccines that primarily consist of live attenuated or inactivated whole pathogens, new generation vaccines offer the promise of more specific immune protection with less adverse effects. However, these subunit antigens are less immunogenic and the lack of an effective adjuvant suitable for human use has severely limited the development of subunit vaccines. We have identified a protein from the helminth parasite Onchocerca volvulus, named O. volvulus activation-associated secreted protein-1 (Ov-ASP-1) that has intrinsic immunostimulatory properties. In preliminary studies, we have demonstrated that recombinant Ov-ASP-1 is a powerful immunostimulatory adjuvant, which stimulates both antibody and cellular responses to a number of model antigens. Our protein adjuvant has a potential advantage because it is a natural protein secreted from a parasite and it does not induce any pathological outcomes. In this SBIR Phase I application, we will test the use of rOv- ASP-1 as an adjuvant for the development of flu vaccines that may overcome the shortcomings of current flu vaccine technology. PUBLIC HEALTH RELEVANCE: Vaccination plays a major role in the control of seasonal influenza virus infection. It is estimated that a vaccine to a new pandemic strain produced using the current system of egg-based vaccine production would not be available for at least six months after the pandemic arises, therefore new methods for rapidly synthesizing vaccines are needed. We have identified a protein (rOV-ASP-1) that has intrinsic immunostimulatory properties. In preliminary studies, we have demonstrated that recombinant Ov-ASP-1 is a powerful immunostimulatory adjuvant, which stimulates both antibody and cellular responses to a number of model antigens. In this SBIR Phase I application, we will test the use of rOv-ASP- 1 as an adjuvant for the development of flu vaccines that may overcome the shortcomings of current flu vaccine technology.